Jobs

Interviews
Job Alerts
Tools

Upskill and Grow with AI

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Path AI insights for smarter career decisions

AI Job Match Score AI-Powered Job Match Against Your Resume and Optimize Your Resume

Career Tools and Resources

Resume Builder Build Professional Resume with Ease

ATS Friendliness Check Check Resume Friendliness for Applicant Tracking Systems

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Co-Pilot (Chrome Extension) Your AI Assistant for Seamless Browsing Efficiency

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
For Employers

Home
>
Jobs in karnataka
>
UST
>
QA Associate - CAPA, Audits & Inspections

QA Associate - CAPA, Audits & Inspections

UST

4 - 8 years

0 Lacs

karnataka

Posted:3 weeks ago| Platform: Shine logo

Apply

Skills Required

capa audit inspections qms platforms ectd lorenz globalsummit

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Quality Assurance (QA) Associate specializing in Corrective and Preventive Actions (CAPA), Audits, and Inspections, you will play a critical role in ensuring compliance and continuous improvement within GMP-regulated environments in the Life Sciences industry. Your primary focus will be managing CAPA processes, supporting audits, and preparing for regulatory inspections to maintain adherence to standards such as GMP, ISO, and ICH guidelines. Key Responsibilities: - Manage Corrective and Preventive Actions (CAPA) by initiating, tracking, and closing CAPA records in alignment with quality objectives. - Conduct root cause analysis using tools like 5 Whys, Fishbone, or Six Sigma techniques. - Collaborate with cross-functional teams to define and implement effective corrective actions. - Monitor CAPA trends, generate reports, and ensure timely implementation and documentation of CAPA activities. - Prepare for and support internal audits and external regulatory inspections, including FDA, EMA, and ISO audits. - Conduct audit readiness assessments, host client audits, respond to findings, and maintain audit schedules and documentation. - Support vendor qualification audits, compliance reviews, and training programs related to CAPA and audit procedures. - Maintain audit trails, compliance tracking systems, and documentation accessibility in electronic systems like Veeva and MasterControl. - Contribute to continuous improvement initiatives, enhancements in Quality Management Systems (QMS), and ensure version control of documents. - Train staff on QMS procedures, documentation best practices, and ensure compliance with industry standards and regulations. Qualifications Required: - Graduate/Postgraduate degree in Pharmacy/Life Sciences or a related field. - 4-6 years of experience in Life Sciences QA specializing in CAPA, Audits, and Inspections. - Proficiency in QMS platforms (e.g., Veeva QMS, MasterControl) and electronic document management systems (EDMS). - Knowledge of eCTD, Lorenz, GlobalSubmit, and experience with CSV/validation support is advantageous. - Familiarity with industry standards and regulations like ISO 9001, ISO 13485, FDA regulations, and Global Health authority requirements. - Excellent communication, collaboration, presentation, stakeholder management, analytical, and problem-solving skills. - Proficiency in MS Office, regulatory work processes, and understanding of Global Regulatory submission requirements. Additional Company Details: (Omitted as no additional details of the company are provided in the job description),

More Jobs at UST

Architect II - Technical SAP ABAP

Bengaluru

12 - 15 yrs

INR 0 - 0 Lacs

Lead I - SAP FICO with PS (Project Systems) and RAR

Bengaluru

5 - 7 yrs

INR 0 - 0 Lacs

Lead II - SAP ABAP

Bengaluru

7 - 9 yrs

INR 0 - 0 Lacs

Procurement

Bengaluru, Karnataka

Experience: Not specified

Salary: Not disclosed

Manual & Python Automation

Bengaluru, Karnataka

Experience: Not specified

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

UST

IT Services and IT Consulting

Aliso Viejo CA

Login to

Please Verify Your Phone or Email

Confirm Action

QA Associate - CAPA, Audits & Inspections